The invention relates generally to medical devices for facilitating visual observation and manipulation of internal tissue and more particularly to devices for facilitating direct intra-tissue visual observation and manipulation of solid distensible tissues, such as muscle tissue, tumors, solid organs, tissue between tissue planes such as preperitoneal tissue, or similar tissue configurations.
Oftentimes, solid tissue formations such as muscle tissue, fatty tissue or tumors, must be operated on or examined to determine whether there is an anomaly within the tissue. There exists a need for a medical instrument which allows an operator to visually inspect and/or operate within the tissue without requiring a large incision in the body to examine or perform operations on the organ or tissue. For example, where the tissue or organ of interest is not a viscus or does not have a cavity within the organ, it is difficult to get a visual image using known devices. Consequently, there exists a need for a medical instrument suitable for intra-tissue dissections and/or for intra-tissue suturing while visually monitoring the area of dissection.
Known intra-cavitary endoscopes, e.g., laparoscopes, pelviscopes, gastroscopes, colonoscopes, etc., are typically designed to facilitate visual examination and manipulation of body cavities, the exterior of viscera and lumen of a viscera. However, no medical instruments are known which facilitate visual observation and simultaneous manipulation or dissecting operations within a relatively solid organ or tissue.
Laparoscopes, for example, find particular use in abdominal surgery. These devices typically include a tubular member which has internal channels for housing various operating instruments. One channel typically houses a telescope for allowing visual observation within the cavity which includes an eye piece and an object lens which typically uses a fiber optic light source to illuminate the interior of the cavity. The object lens is located distal the eye piece. Another channel may be adapted to receive various instruments, such as suturing instruments or grasping devices or other suitable surgical devices. The channels are typically longitudinally located to provide axial arrangement of the telescope and instruments inside the tubular member. Such endoscopes also have a channel for allowing the passage of pressurized gas to expand the cavity of interest to an extent such that a visual image of the selected area can be seen on a display screen and/or seen by the operator through the eye piece connected to the optical telescope.
Consequently, intra-abdominal operations may be facilitated with only a small incision (approximately the size of the diameter of the laparoscope) which generally improves a patient's recovery time. Such devices may also have couplers for connection of laser devices to perform laser surgery.
Although such endoscopes help facilitate intracavity operations by providing a means for generating a visual image of the organ or tissue to be examined in conjunction with the necessary instrumentation for performing an operation on the object or tissue of interest, such devices are not typically suitable for intra-tissue operations or examinations since the object lens is generally unprotected and gets obstructed or covered with tissue debris, blood, or secretion when used to perform intra-tissue operations.
Typical endoscopic procedures that employ rigid endoscopes, generally require the use of a separate irrigation instrument which is inserted into the cavity of interest through an additional incision in the patient so that the area of operation may be washed. Such rigid intra-cavity devices do not have irrigation mechanisms for cleaning the visual observation device. For example, blood or other secretions may cover the object lens thereby negating the impact of visual observation, consequently the endoscope must be removed through a trocar sleeve for cleaning during the operating process. This slows down the operation process and increases the chances of infection since the instrument is removed and reinserted into the patient.
Flexible endoscopes are also known, such as gastroscopes and colonoscopes, which have irrigation channels within the instrument to spray the object lens to remove unwanted secretion or debris and thereby also avoid the necessity of making multiple incisions. However, such instruments are typically designed to be flexible so that they may be inserted through a winding and open channel such as an intestine. These devices are typically ineffective in penetrating solid tissue. As previously mentioned, such endoscope devices are also not suited to distend solid tissue.
Another problem with conventional intra-cavity medical instruments is the attachment method of a trocar sleeve to the patient. The endoscopes are typically inserted into a body cavity through an incision through the skin using a trocar and trocar sleeve as known in the art. A trocar sleeve typically has two opposing open ends to facilitate insertion of the laparoscope or other endoscope into the patient.
Several attachment methods are known for attaching a trocar sleeve at a certain position to the patient so that insertion and movement of the tubular member will not cause the trocar sleeve to move, thereby keeping a substantially airtight seal about the opening through which the tubular member is inserted into the patient. One such trocar, typically referred to as a Hasan trocar, uses a plastic or metallic member which is fixedly engageable with an exterior surface of the trocar sleeve so that a predetermined length of the trocar sleeve may be positioned inside the patient. The plastic or metallic member includes a conically shaped base portion or conical plug with circumferentially parallel ribs which are spaced apart so that the insertion of the base portion into the opening of the patient substantially forms an airtight seal between the trocar sleeve and the patient. The plug is typically inserted into the opening and below the skin line.
The member is fixedly secured to the patient by stitching a top portion of the plastic device, which remains outside the patient, to the outer skin tissue of the patient. The trocar sleeve may be slidably adjusted by loosening and tightening a laterally activating pinching mechanism which is located above the base portion. However, such attachment devices are time-consuming to attach given the two-step process of inserting the conical plug into the patient and subsequently stitching the exteriorly located top portion of the plastic device to the outer skin tissue of the patient.
Other known trocar devices rely solely on internally mounted plug devices to secure the trocar in place. One such known trocar sleeve attachment device includes a threaded base portion which is screwably twisted into the opening of the patient so as to secure the device in place to form an airtight seal between the trocar sleeve and the patient. As with the Hasan device, these devices are also slidably adjustable to the outside of the trocar sleeve via a laterally activated pinching device which may be tightened or loosened via a laterally fixed screw located above the threaded base portion. Another type of internally mounted attachment device similarly has a threaded base portion for screwably attaching to the patient, but instead of a lateral screw-tightening mechanism, uses an axially screw device.
However, such devices typically rely entirely on the threads to adequately engage the opening in the patient so as to provide a sufficient airtight seal. A problem arises given the elastic nature of the skin and subcutaneous fat tissues into which such devices are screwed, such devices typically do not provide adequate attachment when substantial movement of the endoscope is required.
Furthermore, different sized plug devices are required for different sized incisions since each plug has a predetermined size. For example, a small incision requires the use of a small diameter plug whereas a large incision requires a large diameter plug. Consequently, hospitals must maintain a sufficient size inventory of all sized devices. Also, a physician may make many different sized incisions during an operation and therefore require a plurality of different sized plug devices. Hence a need exists for a trocar attachment device which may be adjusted to seal various sized openings and also be adapted for external attachment to the patient to facilitate quick sealing and adjustment.
Consequently, there exists a need for a medical instrument which can be used to visually observe and simultaneously facilitate intra-tissue manipulation of a relatively solid tissue or organ. Such a device should also include a readily adjustable and easily attachable attachment mechanism for forming an airtight seal between the device and the opening in the patient so that movement of the device within the patient does not readily breach the airtight seal.